MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Depression (2361)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator.

Event Description

The mother of the patient reported that the patient had symptom worsening and intermittent relief that occurs daily.Turning the implant off at night has been attempted to resolve the issue which helps for a bit, and the patient has had no falls/trauma or emi related.It was stated that the patient cannot function 99% of the time because stimulation is causing their depression to worsen, and they cannot get out of bed a lot of time, interact with family, think straight, or work.The issues have been going on for the past year prior to date notified and turning stimulation off helps but then all of the sudden the symptoms come back and they have to turn stimulation back on.The patient's depression has begun to manifest into physical symptoms like back pain and physical body pain, with their depression continually deteriorating.The patient's indication for implant is obsessive compulsive disorder and movement disorders.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6167235
• MDR Text Key: 62377952
• Report Number: 3004209178-2016-26248
• Device Sequence Number: 1
• Product Code: MFR
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• Combination Product (y/n): N
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Date Device Manufactured: 10/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR